Safety, Tolerance and Immunogenicity of EuCorVac-19 for the Prevention of COVID-19 in Healthy Adults

EuBiologics

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Other: Normal Saline; Biological: EuCorVac-19

Study type: Interventional

Funder types: Industry

Identifiers

NCT04783311

EuSNAP_COV101

Details and patient eligibility

About

Phase I/II study to determine safety, tolerance and immunogenicity of EuCorVac-19, a recombinant protein vaccine, for the prevention of COVID-19 in healthy adults

Enrollment: 279 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Individuals who voluntarily decide to participate in this study and provide written informed consent

   • Healthy male and female adult at the age of 19 to 50 years (Part A)
   • Healthy male and female adult at the age of 19 to 75 years (Part B)

2. Individuals who are available for all visit procedures including telephone visits during the study period

Exclusion criteria

1. COVID-19 positive based on RT-PCR using upper respiratory tract or lower respiratory tract sampling or COVID-19 antibody positive
2. History of SARS-CoV, MERS-CoV or SARS-CoV-2 infection
3. History of vaccination against SARS-CoV, MERS-CoV or SARS-CoV-2
4. Immune system disorders including immunodeficiency disease
5. Clinically significant abnormalities in clinical laboratory test, ECGs and chest X-ray during screening in the opinion of the investigator
6. Fever within 3 days prior to screening or serious acute or chronic infection within 7 days prior to screening requiring systemic antibiotics or antivirals
7. Evidence or history of serious acute, chronic, or progressive disease which, in the opinion of the investigator, makes the individual ineligible for the study
8. History of severe allergic reactions or severe hypersensitivity reactions to the IP or any of its components
9. History of therapy that might affect immunity: treatment with immunosuppresants or immune modifying drugs, anticancer therapy, or radiotherapy within 3 months prior to screening
10. Women of childbearing potential who do not agree to use medically allowed methods of contraception or to be heterosexually inactive until 60 days after the last dose of the IP
11. Pregnant or breastfeeding woman
12. Treatment with other IPs within 6 months prior to participation in this study
13. Other reasons including medical reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

279 participants in 5 patient groups

Phase 1 - EuCorVac-19 Low dose group

Experimental group

Description:

Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

Treatment:

Other: Normal Saline

Biological: EuCorVac-19

Phase 1 - EuCorVac-19 High dose group

Experimental group

Description:

Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

Treatment:

Other: Normal Saline

Biological: EuCorVac-19

Phase 2 - EuCorVac-19 Low dose group

Experimental group

Description:

Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

Treatment:

Biological: EuCorVac-19

Phase 2 - EuCorVac-19 High dose group

Experimental group

Description:

Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

Treatment:

Biological: EuCorVac-19

Phase 2 - Placebo comparator group

Active Comparator group

Description:

Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval

Treatment:

Other: Normal Saline